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OpenTrials
Completed

NCT Number: NCT04507776

Study To Evaluate The Efficacy And Long-Term Adherence Of Spondyloarthropathies(SpA) Patients On Enbrel

This study is to evaluate local data in Iraqi patients with Spondyloarthropathies on Enbrel treatment with regards to efficacy and adherence using data from the Baghdad Teaching Hospital (Rheumatology Center)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Baghdad, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed SpA patients
  • 18 years of age and older.
  • Did not receive previous other biological treatments.
  • Patients have at least 1 year on Enbrel.

Exclusion criteria

  • Had previously used another biological treatments.
  • Use of etanercept for less than 1 year duration.

Treatment and study plan

etanercept

Drug

Patients with spondyloarthrosis as provided in real world practice

Other names: Enbrel

Primary outcomes

  1. Percentage of Participants With 7 Years Adherence to Etanercept

    Time frame: 7 years [from the data retrieved and observed in 1 month of this study]

    In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported.

Other outcomes

  1. Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment

    Time frame: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]

    BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ [Q5 + Q6/2])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared absolute BASDAI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7.

  2. Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment

    Time frame: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]

    BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ [Q5 + Q6/2])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared change from baseline in BASDAI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7.

  3. Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment

    Time frame: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]

    BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared absolute BASFI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence, last visit was Year 7.

  4. Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment

    Time frame: Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study]

    BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared change from baseline in BASFI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Long Term Adherence and Efficacy of Etanercept in SpA Iraqi Patients: 7 Year Data From Local Registry

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2020
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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